32 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DX-D 300
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58211030500·RETRACTOR, ALL TYPES
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 50mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665038408·
SESAMOIDECTOMY BONE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896082496·SESAMOIDECTOMY BONE CLAMP WITH RATCHET STRONG C...
UNI-ELBOW
FDA UDI
Stryker GmbH·00886385026077·Radio Capitellum, Template, SM
Pulmoguard
FDA UDI
S D I DIAGNOSTICS INC·B279S293103050·
CRYOSURGICAL UNIT AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
FEMORAL HEAD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBL·December 2, 2025
AMSINO MEDICAL USA
FDA Adverse Event
Other
·AMSINO MEDICAL USA·Product code FOZ·May 20, 2009
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
BAXA
FDA Adverse Event
Injury
·BAXA·Product code NEP·May 24, 2011
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014
Artis Q floor, Model Number 10848280
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024